DEVICE: NxSTEP (00718175004845)

Device Identifier (DI) Information

NxSTEP
950-484
In Commercial Distribution
950-484
BIODEX MEDICAL SYSTEMS, INC.
00718175004845
GS1

1
043833813 *Terms of Use
NxSTEP Unweighing System, without Harness
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Mobile gait rehabilitation system, harness-support A mobile assembly of battery-powered devices designed to assist a patient with a walking/balance disability (neurological, muscular, cardiovascular, or orthopaedic in origin) to regain lost motor function, by enabling the patient to walk over ground (i.e., not on a treadmill) whilst supported from above. It consists of a mobile rigid framework on electronically-controlled wheels, a patient harness with suspension assembly, and motion sensors; the device senses patient movements and automatically follows the patient. The patient is supported overhead to assist rehabilitation and provide fall protection. It is intended to be used in a clinical setting under professional supervision.
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FDA Product Code

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Product Code Product Code Name
ITJ Walker, Mechanical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

536e96b3-028e-41d5-b3f0-3e4fc6597a59
May 23, 2019
1
May 15, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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